Long-term effects of tacrolimus for maintenance therapy of lupus nephritis: a 5-year retrospective study at a single center

Abstract

Previously, we reported the short-term effects of tacrolimus in treating lupus nephritis (LN); however, long-term data are lacking. We conducted a retrospective study of 26 adult patients with LN. Tacrolimus was initiated at a dose of 3 mg/day after induction therapy. We retrospectively collected data on renal response; modified lupus nephritis disease activity index (m-LNDAI), including hematuria, proteinuria, complement 3, anti-double-stranded DNA antibody, and estimated glomerular filtration rate (eGFR); and prednisolone (PSL) dose. Three patients discontinued tacrolimus treatment because of related complications, including acute myeloblastic leukemia, tremor, or a general personal choice or a desire to become pregnant. We analyzed data from 23 patients who were treated with tacrolimus over a 5-year period. The mean urinary protein/creatinine ratio decreased from a baseline of 0.24 (min 0.00–max 4.20) to 0.00 (0.00–7.05) at 5 years (p = 0.0134), while eGFR levels remained unchanged throughout the 5 years. The mean m-LNDAI decreased from a baseline of 3.00 (0.00–12.0) to 2.00 (0.00–4.00) at 5 years (p = 0.0074). The mean PSL dose decreased from a baseline of 0.33 (0.00–0.75) mg/kg/day to 0.15 (0.15–0.33) at 5 years (p = 0.001). Our results suggest that tacrolimus is potentially effective for treating LN and that the current dosage was generally well tolerated for long-term maintenance treatment in our patients with LN.

Notes

Acknowledgements

We thank Dr. Yoei Miyabe, who helped with the statistical analysis. We thank Edanz Group (http://www.edanzediting.com/ac) for editing a draft of this manuscript.

Author contributions

Kazunori Karasawa treated the patients and wrote the manuscript. Keiko Uchida treated the patients. Mio Kodama collected the medical data. Takahito Moriyama helped draft the manuscript. Kosaku Nitta drafted the manuscript. All authors contributed to the preparation of the manuscript and approved the final version.

Compliance with ethical standards

Conflict of interest

All authors have declared no conflict of interest.

Informed consent

This study complied with the guidelines of the Declaration of Helsinki and was approved by the Tokyo Women’s Medical University Ethics Committee under Approval Number #4226, January 6, 2017. We received oral consent from all patients and provided them with the opportunity to opt out.